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Nex-Link Spinal Fixation System Variable Crosslink, Model 721-Xx

by Abbott Spine, Inc.

510(k) K052247

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK052247 Date14 Sep 2005ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0604-2011 FDA Unclassified (pre-2012) initiated 1 Dec 2005 on shared 510(k) K052247
    • Terminated Z-0605-2011 FDA Unclassified (pre-2012) initiated 1 Dec 2005 on shared 510(k) K052247
    • Terminated Z-0602-2011 FDA Unclassified (pre-2012) initiated 1 Dec 2005 on shared 510(k) K052247
    • Terminated Z-0603-2011 FDA Unclassified (pre-2012) initiated 1 Dec 2005 on shared 510(k) K052247

    The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KWP
Device Class
Class II
Regulation
21 CFR Part 888.3050
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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